Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017955
Company: VALEANT INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RETIN-A TRETINOIN 0.01% GEL;TOPICAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/17/1978 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/01/2013 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/20/2001 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/10/2002 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf
01/25/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/23/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/10/2002 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf
06/10/2002 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf
01/24/1992 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/1990 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1990 SUPPL-13 Labeling

Label is not available on this site.

08/28/1990 SUPPL-12 Labeling

Label is not available on this site.

12/01/1989 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/11/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/23/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/06/1983 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/29/1981 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1982 SUPPL-4 Labeling

Label is not available on this site.

04/28/1980 SUPPL-3 Labeling

Label is not available on this site.

11/05/1979 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/1979 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/10/2002 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
06/10/2002 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
06/10/2002 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf

RETIN-A

GEL;TOPICAL; 0.01%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RETIN-A TRETINOIN 0.01% GEL;TOPICAL Prescription Yes AB 017955 VALEANT INTL
TRETINOIN TRETINOIN 0.01% GEL;TOPICAL Prescription No AB 075589 PERRIGO PHARMA INTL

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English